POS0466 INTERIM UPDATE ON BASELINE CHARACTERISTICS AND EFFECTIVENESS FROM A PROSPECTIVE OBSERVATIONAL STUDY OF PATIENTS WITH RHEUMATOID ARTHRITIS (RA) TREATED WITH FILGOTINIB (FILOSOPHY)
Authors: R. Caporali, J. Avouac, K. Bevers, G. R. Burmester, T. Debray, F. De Leonardis, K. Harris, N. Betteridge, S. Romero-Yuste, P. Verschueren, M. Zignani, J. Galloway
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Filgotinib (FIL) is a preferential oral Janus kinase (JAK) 1 inhibitor for the treatment of RA. Efficacy of FIL has been demonstrated in clinical trials. To assess effectiveness in a real-world setting, a phase 4 study of FIL (FILOSOPHY; NCT04871919) in patients with RA is ongoing in Europe. <h3>Objectives</h3> To report baseline characteristics and interim efficacy data (up to 6 months) in the first 480 patients treated in FILOSOPHY. <h3>Methods</h3> FILOSOPHY is a prospective, observational study, in which approximately 1500 adults with moderate to severe active RA, who are prescribed FIL for the first time and in accordance with the product label in daily practice, will be enrolled. We report interim baseline demographics, disease characteristics, prior treatments, and reasons for starting FIL. We assessed disease activity at baseline, and Months 1, 3 and 6, via Clinical Disease Activity Index (CDAI) and Disease Activity Score in 28 joints–C-reactive protein (DAS28-CRP) and two electronically collected patient-reported outcome (PRO) measures at baseline, Week 1–4, and Months 3 and 6: pain (using a 10-cm visual analog scale [VAS]) and fatigue (via the Functional Assessment of Chronic Illness Therapy–Fatigue scale [FACIT-F]). The proportion of patients with minimal clinically important difference (MCID) in FACIT-F (≥4.0 change from baseline) and VAS pain (≤–10-mm change from baseline) at Month 6 was assessed. A repeated measurements model was used to estimate the least squares (LS) mean change from baseline in CDAI and FACIT-F. <h3>Results</h3> Of the 480 treated patients by the end of June 2022, 73.1% were female, mean (standard deviation [SD]) age was 57.6 (11.5) years, RA duration was 10.4 (9.4) years, BMI was 27.6 (5.7) kg/m<sup>2</sup>, 28 tender joint count was 8.6 (6.9), and 28 swollen joint count was 5.6 (5.2). A total of 45.2% of patients were positive for rheumatoid factor and/or anti-citrullinated peptide antibody. Over half of patients (57.5%) had received prior biologic disease-modifying antirheumatic drugs (DMARDs; <b>Table 1</b>) and18.3% prior targeted synthetic DMARDs. FIL was started due to inadequate response (36.3%), loss of response (50.6%) or intolerance (non-allergic) (7.7%) to previous treatment (other reasons/missing data accounted for 5.4% of patients). Most patients (91.9%) received FIL 200 mg; 8.1% received FIL 100 mg (<b>Table 1</b>). FIL monotherapy was taken by 52.9% of patients, while 45.6% received FIL in combination with conventional synthetic DMARDs. Improvements from baseline to Month 6 were observed in CDAI (LS mean change [standard error; SE]: –15.8 [1.0]; <b>Figure 1</b> shows median CDAI over time) and DAS28-CRP (LS mean change [SE]: –1.8 [0.1]). Improvements from baseline to Month 6 were also observed for PROs; at Month 6, 54.2% and 65.0% of patients had an MCID from baseline in FACIT-F and VAS pain score, respectively. <h3>Conclusion</h3> Preliminary 6-month data indicate rapid improvements with FIL treatment, which were seen as early as 4 weeks for disease activity and as early as 1 week for pain and fatigue. Similar effects were seen with FIL monotherapy and combination therapy. Long-term follow-up is needed to further evaluate disease outcomes. <h3>Acknowledgements</h3> We thank the physicians and patients who participated in this study. The study was funded by Galapagos NV, Mechelen, Belgium. Publication coordination was provided by Fabien Debailleul, PhD, of Galapagos NV. Medical writing support was provided by Debbie Sherwood, BSc, CMPP (Aspire Scientific, Bollington, UK), and funded by Galapagos NV. <h3>Disclosure of Interests</h3> Roberto Caporali Speakers bureau: AbbVie, Amgen, BMS, Celltrion, Fresenius, Galapagos, Janssen, Lilly, Novartis, Pfizer, UCB, Consultant of: AbbVie, Fresenius, Galapagos, Lilly, Novartis, Pfizer, UCB, Jérôme Avouac Speakers bureau: AbbVie, AstraZeneca, BMS, Eli Lilly, Galapagos, MSD, Novartis, Pfizer, Sandoz, Sanofi, Consultant of: AbbVie, Fresenius Kabi, Galapagos, Sanofi, Grant/research support from: BMS, Fresenius Kabi, Novartis, Pfizer, Karen Bevers Grant/research support from: Galapagos, Gerd Rüdiger Burmester Speakers bureau: AbbVie, Amgen, BMS, Chugai, Galapagos, Lilly, Pfizer, Sanofi, Consultant of: AbbVie, Amgen, BMS, Galapagos, Lilly, Pfizer, Sanofi, Thomas Debray Consultant of: Biogen, Galapagos, Gilead, Francesco De Leonardis Employee of: Galapagos, Kristina Harris Shareholder of: Galapagos, Employee of: Galapagos, Neil Betteridge Consultant of: Amgen, ASIF, Edwards Lifesciences, Eli Lilly, EULAR, Global Alliance for Musculoskeletal Health, Global Alliance for Patient Access, Grunenthal, Heart Valve Voice, Pfizer, Sanofi, Genzyme, Susana Romero-Yuste Speakers bureau: AbbVie, Biogen, BMS, Lilly, Pfizer, Consultant of: Sanofi, Lilly, Grant/research support from: Lilly, MSD, Patrick Verschueren Speakers bureau: AbbVie, Eli Lilly, Galapagos, Roularta, Consultant of: Celltrion, Eli Lilly, Galapagos, Gilead, Nordic Pharma, Sidekick Health, Grant/research support from: Galapagos, Pfizer, Monia Zignani Shareholder of: Galapagos, Employee of: Galapagos, James Galloway Speakers bureau: AbbVie, Biogen, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Roche, UCB, Consultant of: AbbVie, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Grant/research support from: AstraZeneca, Celgene, Gilead, Janssen, Medicago, Novavax, Pfizer.